Inspections - Background

BackgroundFDA conducts inspections of establishments that manufacture, process, pack, or hold FDA-regulated products, before approving products and/or after products are on the market, to determine the establishment’s compliance with laws administered by FDA. Upon completing the inspection, if objectionable conditions are observed, FDA provides the owner of the establishment with a document, called an FDA Form 483, which includes the name of the firm and the date(s) of inspection, and lists the observations made by the investigator during the inspection.

FDA provides initial classification of the inspection based on the observations noted during the inspection, the investigator’s report, and FDA District Office supervisory personnel review. With the exception of instances where procedures indicate that the relevant product center has the right of final classification, the final classification of the inspection is made by the FDA District Office. An inspection classification reflects the compliance status of the establishment at the time of the inspection, based on the observations documented. The conclusions of the inspection are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment's lack of compliance with statute(s) or regulation(s).

A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance. Inspections classified with VAI violations are typically more technical violations of the FDCA.

An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.

If no enforcement action is contemplated, or after enforcement action is concluded, FDA provides inspected establishments with a final inspection report, called an Establishment Inspection Report (EIR), which includes:

Brief history of prior inspectional findings, including any action taken by FDA or corrective action taken by the firm in response to a previous inspection

The investigator’s narrative report

Any refusals, voluntary corrections, or promises made by the firm’s management

Copies of forms the FDA issued to the firm during the inspection, including the FDA Form 483

FDA proactively posts inspection reports (FDA Form 483s and EIRs) in the ORA Electronic Reading Room when a high level of public interest is anticipated. Also, FDA may post in the ORA Electronic Reading Room “frequently requested” inspection reports as defined by the Electronic Freedom of Information Act Amendments of 1996. FDA redacts non-public information, such as trade secrets, from the inspection report before posting it.